Sr. Manager Quality Assurance

Dexcom • Mesa, AZ

1d

About The Position

Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.
We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.
Our Quality organization is at the heart of everything we do. We are a collaborative, mission‑driven team committed to ensuring that every device we bring to market is safe, effective, and meets the highest standards of regulatory compliance. As part of the Quality Assurance (QA) Team, you’ll join a diverse group of professionals who work cross‑functionally with Engineering, Supply Chain, and Operations to uphold our commitment to patient safety and product excellence. We work closely with teams across the company to support design controls, validation activities, CAPA management, supplier quality, and product lifecycle initiatives while keeping focus on producing high quality product for our patients. We believe quality is everyone’s responsibility—and we lead by example.
You will provide technical support for the projects, functions, and strategic objectives of Manufacturing Quality. You will be responsible for Supporting (via team) Materials manufacturing (i.e., Dexthane, DL Copolymer and Drug Formulation), Analytical Lab and strengthen cross-site alignment.
You will be responsible for planning, implementing, and managing compliance of manufacturing and production processes with internal and external safety, quality, and special controls for iCGM (Continuous Glucose Monitor) regulatory requirements.
You will perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
You will assure compliance to in-house and external specifications and standards (i.e., GLP, GMP, ISO, Six Sigma). Provide guidance on NCMR dispositions and investigations and guidance on the CAPAs.
You will design methods and procedures for inspecting, testing, and evaluating the precision and accuracy of sensor manufacturing processes, Chemical Preparation, production equipment, and finished products.
You will manage a team of Quality Engineers supporting Sensor Manufacturing processes and production line.

Requirements

• Knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO 13485 Quality Management Systems).
• Ability to organize and prioritize assignments providing direction to and participation in assigned functional teams.
• Technical writing skills as applied to quality and manufacturing documentation and process development – Experience in creating and revising technical documentation.
• Ability to deal with ambiguity/uncertainty and a willingness to try new/challenging things with a proven track record of working hands-on in a fast-paced environment.
• Ability to use analytical tools (5 Whys, fishbone, FMEA, DOE) to make clear, defensible decisions using risk‑based methodology that balances patient safety, compliance, and business needs.
• Ability to lead root cause analyses with crossfunctional teams and assist your team with writing high-quality investigations, drive containment, corrective, and preventive actions and ensure timely closure of quality records.
• A leader who can influence without authority, coach teams through compliance and improvement, encourage accountability and integrity and empower employees to reach their full professional potential.
• Typically requires a Bachelor’s degree with 13+ years of industry experience
• 5-8 years of previous people management experience

Nice To Haves

• Certification from the American Society for Quality (ASQ) for Quality Engineering, Reliability Engineering, or Certified Quality Manager/Organizational Excellence is preferred.
• Familiar with experimental design, data analysis, and interpretation of experiments.
• Lean Six Sigma Certification

Responsibilities

• Provide technical support for the projects, functions, and strategic objectives of Manufacturing Quality.
• Responsible for Supporting (via team) Materials manufacturing (i.e., Dexthane, DL Copolymer and Drug Formulation), Analytical Lab and strengthen cross-site alignment.
• Responsible for planning, implementing, and managing compliance of manufacturing and production processes with internal and external safety, quality, and special controls for iCGM (Continuous Glucose Monitor) regulatory requirements.
• Perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
• Assure compliance to in-house and external specifications and standards (i.e., GLP, GMP, ISO, Six Sigma).
• Provide guidance on NCMR dispositions and investigations and guidance on the CAPAs.
• Design methods and procedures for inspecting, testing, and evaluating the precision and accuracy of sensor manufacturing processes, Chemical Preparation, production equipment, and finished products.
• Manage a team of Quality Engineers supporting Sensor Manufacturing processes and production line.

Benefits

• A front row seat to life changing CGM technology.
• Learn about our brave #dexcomwarriors community.
• A full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Access to career development through in-house learning programs and/or qualified tuition reimbursement.
• An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level